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 The study, designed to collect real-world, long-term effectiveness
and safety data on Aduhelm, will enroll 6,000 patients over fours
years in the United States, according to details released during the
Alzheimer's Association International Conference.
Patients in the trial will be monitored for up to five years.
The current study is not the highly anticipated confirmatory trial
the U.S. Food & Drug Administration required as part of Aduhelm's
accelerated approval, but is one of the three trials Biogen will
undertake to generate post-approval data on the drug.
The FDA approved the drug on June 7 using its accelerated approval
pathway, which requires a study to confirm the drug works as
intended, and gave a deadline of nine years ending 2029 for the
trial.
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While the FDA approval was initially hailed by patient associations
and doctors long awaiting a treatment for the memory-robbing
disease, some experts have called for a federal probe into the
decision that they claim was made without clear evidence of patient
benefit.
Biogen said the main goal of the current study will be to evaluate
how well Aduhelm slows the progress of Alzheimer's in dosed
patients.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Maju Samuel)
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